Cyclobenzaprine
Other Centrally Acting Agents
- Drug class
- Other Centrally Acting Agents
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 2
- Products on record
- 27
Overview
Cyclobenzaprine is an active pharmaceutical ingredient in the Other Centrally Acting Agents group (M03BX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 24 | May 20, 2026 |
| CA Canada | Health Canada | 3 | May 13, 2026 |
USUnited States· FDA
24 products
Uses
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
CACanada· Health Canada
3 products
Uses
CYCLOBENZAPRINE (cyclobenzaprine hydrochloride) is indicated: As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Cyclobenzaprine should be used only for short periods (up to two or three weeks), because adequate evidence of effectiveness for more prolonged use is not available, and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. 1 Pediatrics Pediatrics (< 15 years of age): The safety and effectiveness of cyclobenzaprine hydrochloride in children below 15 years of age have not been established.
3 Pharmacokinetics).
Drug interactions
Known interactions involving Cyclobenzaprine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 598. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 00b20a8c-debd-e9… · revised May 20, 2026 [PDF]
- [2]Health Canada (DPD) · 02424584 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.